Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial

Bernhardt, J., Langhorne, P. , Lindley, R. I., Thrift, A. G., Ellery, F., Collier, J., Churilov, L., Moodie, M., Dewey, H. and Donnan, G. (2015) Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet, 386(9988), pp. 46-55. (doi: 10.1016/S0140-6736(15)60690-0) (PMID:25892679)

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Abstract

Background: Early mobilisation after stroke is thought to contribute to the effects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke. Methods: We did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteria were randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0–2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561. Findings: Between July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59–0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93–1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation. Interpretation: First mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refining present guidelines; however, clinical recommendations should be informed by future analyses of dose–response associations.

Item Type:Articles
Additional Information:The trial was initially supported by the National Health and Medical Research Council (NHMRC) of Australia (grant numbers 386201 and 1041401). Additional funding was received from Chest Heart and Stroke Scotland (Res08/A114), Northern Ireland Chest Heart and Stroke, Singapore Health (SHF/FG401P/2008), the UK Stroke Association (TSA2009/09), and the UK National Institute of Health Research (HTA Project 12/01/16). NHMRC fellowship funding was provided to AGT (1042600), HD (336102), and JB (1058635). JB also received fellowship funding from the Australia Research Council (0991086) and the National Heart Foundation. The Florey Institute of Neuroscience and Mental Health acknowledges the support received from the Victorian Government via the Operational Infrastructure Support Scheme.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Langhorne, Professor Peter
Authors: Bernhardt, J., Langhorne, P., Lindley, R. I., Thrift, A. G., Ellery, F., Collier, J., Churilov, L., Moodie, M., Dewey, H., and Donnan, G.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:Lancet
Publisher:Elsevier
ISSN:0140-6736
ISSN (Online):1474-547X
Published Online:16 April 2015
Copyright Holders:Copyright © 2015 Bernhardt et al.
First Published:First published in Lancet 386(9988): 46-55
Publisher Policy:Reproduced under a Creative Commons License

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